Perfusion system with rfid feature activation

ABSTRACT

The disclosure pertains to a perfusion system that is easy to set-up, use and monitor during a bypass procedure. In some embodiments, the disclosure pertains to a perfusion system in which at least some of the disposable components used with the perfusion system are configured to be able to communicate set-up and/or operational parameters to the perfusion system in order to unlock further functionality within the perfusion system.

TECHNICAL FIELD

The disclosure pertains generally to perfusion systems and moreparticularly to integrated perfusion systems configured to communicatecomponent-specific information between system components.

BACKGROUND

Perfusion entails encouraging physiological solutions such as bloodthrough the vessels of the body or a portion of a body of a human oranimal. Illustrative examples of situations that may employ perfusioninclude extracorporeal circulation during cardiopulmonary bypass surgeryas well as other surgeries. In some instances, perfusion may be usefulin providing extracorporeal circulation during various therapeutictreatments. Perfusion may be useful in maintaining the viability of bodyparts such as specific organs or limbs, either while the particular bodypart remains within the body, or while the body part is exterior to thebody such as for transplantation or if the body part has beentemporarily removed to provide access to other body structures. In someinstances, perfusion may be used for a short period of time, typicallydefined as less than about six hours. In some cases, perfusion may beuseful for extended periods of time that are greater than about sixhours.

In some instances, blood perfusion systems include one or more pumps inan extracorporeal circuit that is interconnected with the vascularsystem of a patient. Cardiopulmonary bypass (CPB) surgery typicallyrequires a perfusion system that allows for the temporary cessation ofthe heart by replacing the function of the heart and lungs. This createsa still operating field and allows for the surgical correction ofvascular stenosis, valvular disorders, and congenital heart and greatvessel defects. In perfusion systems used for cardiopulmonary bypasssurgery, an extracorporeal blood circuit is established that includes atleast one pump and an oxygenation device to replace the functions of theheart and lungs.

More specifically, in cardiopulmonary bypass procedures, oxygen-poorblood (i.e., venous blood) is gravity-drained or vacuum suctioned from alarge vein entering the heart or other veins (e.g., femoral) in the bodyand is transferred through a venous line in the extracorporeal circuit.The venous blood is pumped to an oxygenator that provides for oxygentransfer to the blood. Oxygen may be introduced into the blood bytransfer across a membrane or, less frequently, by bubbling oxygenthrough the blood. Concurrently, carbon dioxide is removed across themembrane. The oxygenated blood is then returned through an arterial lineto the aorta, femoral, or other main artery.

SUMMARY

According to an embodiment of the present invention, an integratedperfusion system includes a heart lung machine having a plurality ofpump modules, each pump module having a control unit. A controller is incommunication with each of the control units. An input device is incommunication with the controller and is configured to acceptoperational settings information from a user. An output device is incommunication with the controller and is configured to displayoperational parameters of the plurality of pump modules. The integratedperfusion system includes a data management system that is incommunication with the controller.

The data management system includes an RF sensor and a processor incommunication with the RF sensor. One or more disposable elements areconfigured to be used in conjunction with the heart lung machine andinclude an RFID tag programmed with identifying information that can beread by the RF sensor and used by the processor to unlock functionalitywithin the data management system.

According to another embodiment of the present invention, an integratedperfusion system includes a heart lung machine and a data managementsystem, the data management system including an RF sensor. Theintegrated perfusion system may be configured by attaching a disposablecomponent having an RFID tag to the heart lung machine, reading the RFIDtag with the RF sensor, unlocking functionality within the datamanagement system in accordance with information read from the RFID tag,and operating the unlocked functionality.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an integrated perfusion systemincluding a heart lung machine and a data management system inaccordance with an embodiment of the invention.

FIG. 2 is a flow diagram illustrating a method that can be carried outby the integrated perfusion system of FIG. 1.

FIG. 3 is a flow diagram illustrating a method that can be carried outby the integrated perfusion system of FIG. 1.

FIG. 4 is a schematic illustration of a heart lung machine pack that maybe utilized with the integrated perfusion system of FIG. 1.

FIG. 5 is a schematic illustration of a perfusion system in accordancewith an embodiment of the invention.

FIG. 6 is an illustration of a blood level sensor that may be utilizedwith the perfusion system of FIG. 5.

FIG. 7 is an illustration of a blood level sensor incorporated into alabel that may be utilized with the perfusion system of FIG. 5.

FIG. 8 is an illustration of a blood reservoir including a blood levelsensor in accordance with an embodiment of the invention.

FIG. 9 is an illustration of a hard shell blood reservoir including ablood level sensor in accordance with an embodiment of the invention.

FIG. 10 is an illustration of a soft shell blood reservoir including ablood level sensor in accordance with an embodiment of the invention.

FIG. 11 is a flow diagram illustrating a method that can be carried outusing the perfusion system of FIG. 5.

FIG. 12 is an illustration of a blood reservoir including a blood levelsensor in accordance with an embodiment of the invention.

FIG. 13 is an illustration of a blood reservoir including a blood levelsensor in accordance with an embodiment of the invention.

FIG. 14 is a graph illustrating the relationship between VO2 and DO2 inan athlete under physical exercise.

FIG. 15 is a graph illustrating the relationship between VO2 and DO2 ina patient under cardiac operation.

FIG. 16 is a graph illustrating the relationship between VCO2 and VO2.

FIG. 17 is a graph illustrating the relationship between LAC and VCO2i.

FIG. 18 is a schematic illustration of an embodiment of a perfusionsystem in accordance with an embodiment of the invention.

FIG. 19 is a block diagram illustrating a monitoring system inaccordance with an embodiment of the invention.

FIG. 20 is a schematic illustration of a screen capture in accordancewith an embodiment of the invention.

FIG. 21 is a schematic illustration of a screen capture in accordancewith an embodiment of the invention.

FIG. 22 is a schematic illustration of a screen capture in accordancewith an embodiment of the invention.

FIG. 23 is a schematic illustration of a screen capture in accordancewith an embodiment of the invention.

DETAILED DESCRIPTION

The disclosure pertains to a perfusion system that is easy to set-up,use and monitor during a bypass procedure. In some embodiments, thedisclosure pertains to a perfusion system in which at least some of thedisposable components used with the perfusion system are encoded withset-up and/or operational parameters. In some embodiments, thedisclosure pertains to a perfusion system in which at least some of thedisposable components used with the perfusion system are encoded withidentifying information that can unlock additional functionality withinthe perfusion system.

In some embodiments, the disclosure pertains to a blood level sensorthat can be used to monitor a blood level or volume within a bloodreservoir. The blood level sensor may be utilized in an integratedperfusion system in which the disposable components are configured, asnoted above, to communicate with the perfusion system. In someembodiments, the blood level sensor may be utilized with a perfusionsystem lacking communication with disposables.

FIG. 1 is a schematic illustration of an integrated perfusion system 10.The integrated perfusion system 10 includes a heart lung machine (HLM)12 and a disposable element 14. In some embodiments, as illustrated, theintegrated perfusion system 10 also includes a data management system(DMS) 29. While the HLM 12 and the DMS 29 are illustrated as distinctcomponents, it will be appreciated that in some embodiments, at leastsome of the functionality of the DMS 29 may be integrated into the HLM12. In some embodiments, the HLM 12 and the DMS 29 are modularcomponents or systems that can be connected together as desired, or usedseparately.

In some instances, at least some of the functionality described withrespect to the DMS 29 may instead be incorporated into an inline bloodmonitor, or ILBM. An ILBM may be connected to the HLM 12 and may measureand/or monitor data directly via a sensor on a blood line. In someembodiments, an ILBM may receive information from the HLM 12 and/or theDMS 29. An ILBM may accept manually inputted data, and may display datathat is manually inputted or received from the HLM 12 or other devices.

It will be appreciated that while only a single disposable element 14 isshown for ease of illustration, in many embodiments a plurality ofdifferent disposable elements 14 may be utilized in combination with theHLM 12. Each of the HLM 12, the disposable element 14 and the DMS 29will be described in greater detail subsequently. The HLM 12 includes anumber of different components. It is to be understood that theparticular components illustrated herein as being part of the HLM 12 ismerely an example, as the HLM 12 may include other components ordifferent numbers of components.

In the illustrated embodiment, the HLM 12 includes three pump modules16, but may include as few as two pump modules 16 or as many as six orseven pump modules 16. In some embodiments, the pump modules 16 may beroller or peristaltic pumps. In some embodiments, one or more of thepump modules 16 may be centrifugal pumps. Each of the pump modules 16may be used to provide fluid for delivery to or removal from the heartchambers and/or surgical field. In an illustrative but non-limitingexample, one pump module 16 draws blood from the heart, another providessurgical suction and a third provides cardioplegia fluid (high potassiumsolution to arrest the heart). Additional pump modules 16 (not shown)may be added to provide additional fluid transfer.

Each pump module 16 includes a control unit 18. In some embodiments,each control unit 18 may be configured to operate and monitor theoperation of the particular pump module 16 to which it is attached orotherwise connected to. In some embodiments, each control unit 18 mayinclude one or more input devices (not illustrated) such as switches,knobs, buttons, touch screens and the like so that the perfusionist mayadjust the operation of the particular pump module 16. Each pump module16 may include an alphanumeric display that the control unit 18 can useto display, for example, the value of a setting, the value of a currentoperating parameter, confirmation that the pump module 16 is operatingnormally, and the like.

The HLM 12 includes a controller 20 that is in communication with thecontrol units 18 and that is configured to operate the HLM 12. In someembodiments, the controller 20 is configured to monitor one or moresensors that may be distributed on the HLM 12 and/or within thedisposable element 14 to monitor operation of the HLM 12. Examples ofsuch sensors (not illustrated for ease of illustration) include but arenot limited to flow meters, pressure sensors, temperature sensors, bloodgas analyzers and the like.

While the control units 18 and the controller 20 are illustrated asdistinct elements, in some embodiments it is contemplated that theseelements may be combined in a single controller. In some embodiments, itis contemplated that the control units 18, in combination, may beconfigured to operate the HLM 12, thereby negating a need for thecontroller 20.

The controller 20 communicates with an input device 22 and an outputdevice 24. The input device 22 may be used by the perfusionist to enterinformation that is not otherwise entered into the control units 18. Theoutput device 24 may be used by the HLM 12 to display pertinentinformation to the perfusionist. In some embodiments, the input device22 may be a key pad, a keyboard, a touch screen, and the like. In someembodiments, the output device 24 may be a monitor. In some embodiments,either of the input device 22 and/or the output device 24 may be acomputer such as a personal computer, a laptop computer, a notebookcomputer or a tablet computer. In some cases, the input device 22 andthe output device 24 may be manifested in a single computer.

In some embodiments, the DMS 29 may be considered as functioning as aflight recorder, recording data from a variety of sources, including theHLM 12 and various external sensors and monitoring devices. In someinstances, as illustrated, the DMS may include an RF sensor 26 and aprocessor 27. The DMS 29 may communicate with the HLM 12. In someembodiments, as described herein, the DMS 29 may also provide additionalfunctionality that can be unlocked during use of the HLM 12 and/or theDMS 29.

The DMS 29 is configured to receive and record data from the HLM 12. Insome embodiments, the DMS 29 may receive and record data from othersources as well, such as external devices. The DMS 29 may include aninput device that permits a user to manually enter information. In someembodiments, as discussed herein, the DMS 29 may be configured tooperate and display additional functionality. In some embodiments, theDMS 29 may be configured such that at least some of the disposablecomponents 14 used with the integrated perfusion system 10 are encodedwith identifying information that can unlock additional functionalitywithin the DMS 29. A variety of different additional functionality maybe unlocked, depending on the identity of the disposable component.

In some embodiments, the DMS 29 may be configured to operate and displaya metabolic algorithm. An illustrative but non-limiting example of asuitable metabolic algorithm is known as the Ranucci algorithm. TheRanucci algorithm provides continuous and real-time informationregarding the patient's oxygen delivery (DO2) and their carbon dioxideproduction values (VCO2), as well as the adequacy of the DO2 withrespect to the patient's metabolic requirements. The Ranucci algorithmis described, for example, in U.S. Pat. Nos. 7,435,200; 7,927,286; and7,931,601, which are incorporated by reference herein.

The RF sensor 26 may be configured to receive information from an activeRFID tag placed on the disposable element 14, including theaforementioned identity of the disposable component.

In some embodiments, the RF sensor 26 may be a hand held device that isused to scan a passive RFID tag on the disposable element 14. Accordingto other embodiments, the RF sensor 26 is replaced with any of a varietyof known wireless communication receivers. The disposable element 14includes an RFID tag 28. According to various embodiments, thedisposable element 14 includes either an active RFID tag or a passiveRFID tag (or both) configured to communicate with the RF sensor 26. Inother embodiments, the RFID tag 28 is replaced with any of a variety ofknown wireless communication transmitters.

Passive RFID tags lack a power supply, and instead are powered by aninduced current caused by an incoming radio-frequency scan. Becausethere is no onboard power supply, a passive RFID tag is smaller and lessexpensive. An active RFID tag includes an onboard power supply such as abattery. While this increases the size and expense of the RFID tag, anadvantage is that the RFID tag can store more information and cantransmit further. RFID tags, whether active or passive, may be selectedto transmit at a variety of frequencies depending on need. Optionsinclude low frequency (about 100 to 500 kilohertz), high frequency(about 10 to 15 megahertz), ultra high frequency (about 860 to 960megahertz) and microwave (about 2.45 gigahertz).

As noted above, the disposable element 14 may be considered asgenerically representing one, two or a plurality of different disposableelements that may be used in conjunction with the HLM 12. Illustrativebut non-limiting examples of disposable elements 14 include tubing sets,blood reservoirs, oxygenators, heat exchangers and arterial filters. Insome embodiments, a tubing set includes a number of different tubes,potentially of different lengths and sizes, for providing fluid flowbetween components of the HLM 12 as well as providing fluid flow betweenthe HLM 12 and a patient.

In some embodiments, the disposable element 14 may be a blood reservoirsuch as a venous blood reservoir, a vent blood reservoir, a cardiotomyor suction blood reservoir. In some embodiments, the disposable element14 may be a blood reservoir that combines one or more of a venous bloodreservoir, a vent reservoir and/or a suction reservoir in a singlestructure. In some embodiments, one or more of the aforementionedsensors may be disposable elements that include an RFID tag 28 either toprovide information identifying the sensor or even for transmittingsensed values to the controller 20.

The RFID tag 28 may be attached to the disposable element 14 in anyappropriate manner. In some embodiments, the RFID tag 28 may beadhesively secured to the disposable element 14. In some embodiments,the RFID tag 28 may be molded into the disposable element 14. In someembodiments, the RFID tag 28 may be a stand alone card, similar in sizeand shape to a credit card, that may simply be packed with thedisposable element 14 in such a way that it can be removed by the userand swiped by the RF sensor 26. However the RFID tag 28 is attached, theRFID tag 28 may be programmed with or otherwise configured to include awide variety of information pertaining to the disposable element 14.

In some embodiments, the RFID tag 28 may include data or identifyinginformation for the disposable element 14. Illustrative but non-limitingexamples of identifying information include the name of the particulardisposable element 14, a reference code, a serial number, a lot number,an expiration date and the like. In some embodiments, this informationmay be communicated to the controller 20 and may, for example, be usedby the controller 20 to confirm that the proper disposable elements 14are being used for a particular setting, patient or the like. As anexample, the controller 20 may recognize that a pediatric tubing set isbeing used in combination with an adult-sized blood reservoir or othercomponent. As another example, the controller 20 may recognize that anexpected component is missing. There are a variety of other potentialmismatches in equipment that may be recognized by the controller 20 as aresult of the information provided by the RFID tag 28 attached to eachof the one or more disposable elements 14.

In some embodiments, the RFID tag 28 may include descriptive or designinformation for the disposable element 14. Illustrative but non-limitingexamples of descriptive or design information include specificmaterials, a list of components, priming volume of a component or tubingcircuit, tubing size, tubing length, minimum and maximum workingpressures, minimum and maximum working volume, and the like. In someembodiments, this information may be communicated to the controller 20and may be used by the controller 20 to at least partially configureand/or operate the HLM 12. As an example, the controller 20 may use thesizing information provided from each of the disposable elements 14 todetermine a working blood volume for the HLM 12.

In some embodiments, the information obtained from the RFID tag 28 mayalso be provided to the perfusionist. In some embodiments, the outputdevice 24 may be configured to provide alphanumeric or graphicalrepresentations of the obtained information. In some cases, the RFID tag28 may include instructional information that may be displayed by theoutput device 24 in order to instruct the perfusionist in optimal setupand/or operation of a particular disposable element 14. The RFID tab 28may include warning information that can be transmitted from the RFIDtag 28 and displayed on the output device 24. In some embodiments, thiswarning information may supplement or even replace warning informationthat might otherwise be included as printed materials packaged with thedisposable elements 14.

In various embodiments, the output device 24 may be a computer such as apersonal computer, a laptop computer, a notebook computer or a tabletcomputer. In some embodiments, the RFID tag 28 may include displayableinformation that, for example, suggests an optimal circuit design basedupon the specific components being used, or perhaps updated useinstructions. In some embodiments, information from the RFID tag 28 isdisplayed on the DMS 29.

In some embodiments, the RFID tag 28 may include information that amanufacturer of the disposable element 14 wants to provide to the user.Examples of such information may include technical features of thedisposable element 14 that have changed from a previous version or evena previous batch. Another example includes information that can bedisplayed by the output device 24 that require the user to acknowledgereceipt of the information before the controller 20 proceeds with aparticular procedure. In some cases, the RFID tag 28 may receive errormessages from the DMS 29 and/or the controller 20, and the RFID tag 28may then be returned to the manufacturer, thereby providing themanufacturer with feedback regarding the performance of the disposableelement 14 as well as other components.

In some embodiments, the RFID tag 28 may include information that can beused by an inventory tracking system. In some embodiments, the inventorytracking system may be in communication with the perfusion system 10. Insome embodiments, the inventory tracking system may independently anddirectly receive information from the RFID tag 28 without communicatingthrough the perfusion system 10.

FIG. 2 is a flow diagram illustrating a method that may be carried outusing the perfusion system 10 of FIG. 1. A disposable element 14 havingan RFID tag 28 may be attached to the HLM 12, as generally shown atblock 30. At block 32, the RFID tag 28 is read. As noted above, the RFIDtag 28 may be an active RFID tag or a passive RFID tag. In someembodiments, the RFID tag 28 may be read before the disposable element14 is attached to the HLM 12. In some embodiments, the RFID tag 28 maybe read after attachment. At block 34, the HLM 12 is configured based atleast in part upon information that was read from the RFID tag 28 atblock 32. In some embodiments, the controller 20 automaticallyconfigures the HLM 12 in response to this information. In someembodiments, at least some of the information read from the RFID tag 28may be captured by the DMS 29.

FIG. 3 is a flow diagram illustrating a method that may be carried outusing the perfusion system 10 of FIG. 1. A disposable element 14 havingan RFID tag 28 may be attached to the HLM 12, as generally shown atblock 30. At block 32, the RFID tag 28 is read. The RFID tag 28 may beread either before or after the disposable element 14 is attached to theHLM 12. At block 34, the HLM 12 is configured based at least in partupon information that was read from the RFID tag 28 at block 32. In someembodiments, the controller 20 automatically configures the HLM 12 inresponse to this information. At least some of the information read fromthe RFID tag 28 may be displayed on the output device 24, as seen atblock 36, or on the DMS 29.

FIG. 4 is a schematic illustration of a heart lung machine pack 38 thatmay be utilized with the perfusion system 10 of FIG. 1. In someembodiments, the heart lung machine pack 38 may include all of thedisposable elements 14 that will be used together for a particularpatient and may be customized for the particular patient. In someembodiments, the heart lung machine pack 38 may include a housing 40that, once filled, can be sealed up to keep the contents clean andsterile

In the illustrated embodiment, the heart lung machine pack 38 includes atubing set 42 and a disposable component 44. The tubing set 42 mayinclude a plurality of different tubes. The disposable component 44 maybe any of the disposable components discussed above with respect to thedisposable element 14. In some embodiments, the heart lung machine pack38 will include a plurality of different disposable components 44. Thetubing set 42 includes a first RFID tag 46 while the disposablecomponent 44 includes a second RFID tag 48. As discussed above, each ofthe first RFID tag 46 and the second RFID tag 48 may be either active orpassive RFID tags and may include readable information pertaining to thecomponent to which they are attached. In some instances, the housing 40may include a third RFID tag 50 that, for example, identifies thecontents of the heart lung machine pack 38. In some embodiments, thefirst RFID tag 46 and the second RFID tag 48 may not be included, as thethird RFID tag 50 may be encoded with all of the information for thetubing set 42 and the disposable component 44.

FIG. 5 is a schematic illustration of a perfusion system 52. Theperfusion system 52 includes an HLM 54 that in some embodiments may besimilar in structure and operation to the HLM 12 discussed with respectto FIG. 1. The perfusion system 52 also includes a blood reservoir 56, ablood level sensor 58 and a controller 60. The blood reservoir 56 may bea venous blood reservoir, a vent blood reservoir, a cardiotomy orsuction blood reservoir. In some embodiments, the blood reservoir 56 maybe a blood reservoir that combines one or more of a venous bloodreservoir, a vent reservoir and/or a suction reservoir in a singlestructure.

The blood level sensor 58 may be configured to continuously monitor avariable blood level within the blood reservoir 56. The blood levelsensor may be chosen from a variety of different sensing technologies.In some embodiments, as will be discussed subsequently with respect toFIGS. 12 and 13, the blood level sensor 58 may be an ultrasonic sensorin which ultrasound is used to detect the blood level within the bloodreservoir 56. In some embodiments, the blood level sensor 58 may be anoptical sensor in which a laser beam or light from an infrared lightsource is reflected by the liquid-air interface and the reflected lightbeam is detected by the blood level sensor 58. According to exemplaryembodiments, the blood level sensor 58 is an optical distance sensor ofthe type commercially sold by Leuze electronic GmbH located inOwen/Teck, Germany (e.g., ODSL8, ODSL 30, or ODS 96). In someembodiments, the blood level sensor 58 may be a load cell or scale thatis configured to measure a mass of the blood reservoir 56 and therebydetermine the volume of blood therein.

In some embodiments, the blood level sensor 58 may be a capacitivesensor (better illustrated in subsequent Figures) that outputs anelectrical signal that is proportional to or otherwise related to ablood level within the blood reservoir 56. The electrical signal may becommunicated in either a wired or wireless fashion to the controller 60.While the controller 60 is shown as a distinct element, in someembodiments the controller 60 is manifested as part of a controller(similar to the controller 20) operating the HLM 54.

In some embodiments, the blood level sensor 58 may be modeled aftercapacitive sensors (e.g., CLC or CLW series) available commercially fromSensortechnics GmbH located in Puchheim, Germany, which are configuredto provide contact-free measurement of continuous liquid level. Thesensor available from Sensortechnics may be disposed on an outer surfaceof a container and provides an electrical signal representative of theliquid level within the container. In some instances, the Sensortechnicssensor may be spaced as much as about five millimeters from the liquidwithin the sensor, with no more than about twenty percent air gapbetween the sensor and the liquid. According to various embodiments, thecapacitive sensor 58 is molded inside the blood reservoir 56, such thatonly the connector is accessible outside the reservoir. In theseembodiments, the sensor 58 is protected by the plastic material of theblood reservoir.

In some embodiments, the sensor may undergo an initial configuration toadapt the sensor to the particulars of the container itself as well asthe liquid within the container. In some embodiments, the blood levelsensor 58 has a five pin electrical connection, including a voltagesource, an analog signal out, a digital signal out, a teach-in pin and aground. In some embodiments, the level sensor 58 is a capacitive sensorsuch as the Balluff SmartLevel sensor commercially sold by Balluff GmbHlocated in Neuhausen, Germany.

The controller 60 may receive an electrical signal that is proportionalto or at least related to a blood level within the blood reservoir 56.The controller 60 may calculate a blood volume based on this electricalsignal as well as a known shape or geometry of the blood reservoir 56.In some embodiments, the blood reservoir 56 may include an RFID tag (notillustrated) that provides the controller 60 with information pertainingto the known geometry of the blood reservoir 56.

If the blood reservoir 56 is a hard shell blood reservoir, the knowngeometry of the blood reservoir 56 may include the cross-sectional areaof the blood reservoir 56, or a width and depth of the blood reservoir56 as well as details on how this cross-sectional area varies relativeto height within the blood reservoir 56. If the blood reservoir 56 is asoft shell reservoir, the known geometry may be based at least in partupon a known lateral expansion rate of the soft shell reservoir relativeto the blood level within the blood reservoir 56.

As can be seen in FIG. 6, the blood level sensor 58 includes a firstelongate electrode 60 and a second elongate electrode 62. The firstelongate electrode 60 and the second elongate electrode 62 are disposedalong a flexible substrate 64. In some embodiments, the flexiblesubstrate 64 may include an adhesive layer that can be used to securethe blood level sensor 58 to the blood reservoir 56. A connector socket66 is secured to the flexible substrate 64 and is electrically connectedto the first elongate electrode 60 and the second elongate electrode 62in order to permit an electrical connection between the first and secondelectrodes 60, 62 and an electrical cable (not illustrated in thisFigure). In some embodiments, rather than an elongate sensor, the bloodlevel sensor 58 may include two or more distinct SMARTLEVEL™ capacitivesensors such as those available commercially from Balluff. These sensorsmay provide a binary, yes/no signal. By locating several of thesesensors at differing levels proximate the blood reservoir 56, the bloodlevel within the blood reservoir 56 may be determined.

In some embodiments, the blood level sensor 58 may be attached to orotherwise integrated into a label 68 as seen in FIG. 7. The label 68 mayinclude various indicia 70 such as use instructions, volume indicatorsand the like. In some embodiments, the label 68 may include an adhesiveside for attachment to an outer surface of the blood reservoir 56. Insome embodiments, the label 68 is oriented on the blood reservoir suchthat a lower portion of the blood level sensor 58 is aligned at or neara bottom of the blood reservoir 56.

In some embodiments, the blood level sensor may be an ultrasonic bloodlevel sensor, as illustrated in FIGS. 12 and 13. FIG. 12 is anillustration of a blood reservoir 82 that contains a volume of blood.The volume of blood defines an interface 84 between the volume of bloodand the air or other fluid within the blood reservoir 82. In someembodiments, an ultrasonic transducer 86 that is located at or near alower surface of the blood reservoir 82 can be used to locate theinterface 84 by transmitting ultrasonic waves 88 towards the interface84. The reflectance of the ultrasonic waves 88 depend at least in partupon the fluid they are passing through. Thus, by measuring thereflectance, the ultrasonic transducer 86 can determine how far away theinterface 84 is and thereby determine the fluid level. Based on thefluid level and the geometric configuration of the blood reservoir 82, acontroller may determine the blood volume within the blood reservoir 82.In some embodiments, a cable 90 transmits a signal from the ultrasonictransducer 86 to the controller. In some embodiments, the information istransmitted wirelessly, such as via an RFID tag attached to theultrasonic transducer.

FIG. 13 is similar to FIG. 12, but shows a blood reservoir 92 having ablood volume defining an interface 94. In this embodiment, an ultrasonictransducer 96 is located at or near a top of the blood reservoir 92 andtransmits ultrasonic waves 98 downward towards the interface 94. In someembodiments, a cable 100 transmits a signal from the ultrasonictransducer 96 while in other embodiments this is done wirelessly, suchas with an RFID tag attached to the ultrasonic transducer 96. A primarydifference between the embodiments shown in FIGS. 12 and 13 is that inFIG. 12, the interface 84 is detected from below, or through the blood,while in FIG. 13 the interface 94 is detected from above, or through theair.

In some embodiments, the blood level sensor may be an infrared (IR)light blood level sensor. In some embodiments, an infrared light sourcepositioned at or near a lower surface of the blood reservoir 82 may beused to locate a fluid/air interface within the blood reservoir 82 bytransmitting infrared light towards the interface. Alternatively, theinfrared light blood level sensor may be located above the interface. Insome embodiments, the infrared light blood level sensor may be located ashort distance away from the blood reservoir 82 and thus can be attachedto a mechanical holder for the blood level reservoir 82.

In some instances, the infrared light is reflected back towards theinfrared light blood level sensor. By measuring the reflectance, thelocation of the interface may be determined. In some embodiments, theinfrared light travels through the blood to an infrared light sensorlocated opposite the infrared light blood level sensor. By detectingchanges in the received light, the interface location may be determined.By combining the interface location with known geometric parameters ofthe blood reservoir 82, the controller 20 can determine the blood volumewithin the blood reservoir 82. In some embodiments, this information istransmitted wirelessly to the controller 20, such as via an RFID tagattached to the infrared light blood level sensor.

FIG. 8 is an illustration of the blood level sensor 58 attached to theblood reservoir 56. An electrical cable 72 provides an electricalconnection between the blood level sensor 58 and the controller 60. Theelectrical cable 72 includes a plug 73 that is configured to connect tothe electrical connector 66. In some embodiments, the plug 73 includescircuitry that converts a detected capacitance into a voltage signalthat the controller 60 can use to calculate the blood volume. In someembodiments, the plug 73 further includes circuitry to calculate theblood volume.

As noted above, the blood reservoir 56 may be either a hard shellreservoir or a soft shell reservoir. FIG. 9 illustrates a hard shellreservoir 74 bearing the blood level sensor 58 while FIG. 10 illustratesa soft shell reservoir 76 including the blood level sensor 58. In eithercase, the reservoir may be constructed to include the blood level sensor58. In some embodiments, the blood level sensor 58 may be adhesivelysecured to an existing blood reservoir.

FIG. 11 is a flow diagram illustrating a method that may be carried outusing the perfusion system 52 of FIG. 5. A capacitance between first andsecond electrodes may be detected, as referenced at block 78. In someembodiments, as discussed above, the capacitance may be converted intoan electrical signal representing the blood level by circuitry withinthe plug 73. In embodiments using the CLC series Sensortechnics sensor,for example, the sensor will output a voltage between 0.5 and 4.5 volts.Assuming the sensor pad is appropriately located on the reservoir, thisvoltage indicates a level or height of the liquid in the reservoir. Atblock 80, the controller 60 may calculate a blood volume that is basedupon the detected capacitance and a known dimensions or geometry of theblood reservoir 56. In some embodiments, the controller 60 (or othercircuitry within the HLM 54) may provide the circuitry in the plug 73with sufficient information (e.g., dimensions or geometry) regarding theblood reservoir 56 to permit the circuitry to perform the blood volumecalculation. In some embodiments, the calculated blood volume iscommunicated to the HLM 54 so that it may adjust an operating parameterof the HLM 54. In various exemplary embodiments, the HLM 54 may alter apump speed to either increase or decrease blood flow into or out of theblood reservoir 56. It may be important, for example, to prevent theblood level in the reservoir 56 from moving below a certain minimumlevel or volume. Accordingly, in various embodiments, the HLM 54 willcompare the blood level or volume to this minimum level and adjust pumpspeed appropriately.

According to other embodiments, the HLM 54 may use the blood volumeinformation for a variety of applications, including for exampleauto-regulation of pump occlusion, auto-loading of pump segments,conducting automatic occlusivity testing, performing automatic priming,automatic recirculating and debubbling, conducting automatic pressuretests, or performing automatic system emptying.

In some embodiments, and as noted above, the perfusion system 10 may beconfigured such that at least some of the disposable components usedwith the perfusion system 10 are encoded with identifying informationthat can unlock additional functionality within the perfusion system. Avariety of different additional functionality may be unlocked, dependingon the identity of the disposable component.

In some embodiments, for example, if the disposable component is orotherwise includes a tubing set (such as the tubing set 42 shown in FIG.4), the tubing set may include an RFID tag (such as the 1^(st) RFID 46shown in FIG. 4) that is programmed or otherwise includes informationthat can be used by the perfusion system 10 to determine the primingvolume of a blood circulation system. The blood circulation system mayinclude only items included in the tubing set, or the blood circulationsystem may include additional items.

The presence of the tubing set may enable the DMS 29 to operate anddisplay a priming volume simulator. In some embodiments, for example ifa different tubing set is used, or perhaps a tubing set from a differentmanufacturer, the priming volume simulator may be disabled or otherwisenot permitted to function. Hence, the presence of the particular tubingset (or other disposable component) may unlock the additionalfunctionality of a priming volume simulator.

In some embodiments, the DMS 29 may be configured to operate and displayan algorithm that monitors and/or provides data related to a patient'smetabolism. In some embodiments, the algorithm may be unlocked by theDMS 29, depending on the identity of the disposable component 14. Whilea variety of different algorithms are known and may be unlocked by theDMS 29, an illustrative but non-limiting example of an algorithm thatcan be programmed into the perfusion system 10 and that may be unlockedif appropriate disposable components 14 are used includes a primingvolume simulator. Another example is a metabolic algorithm is known asthe Ranucci algorithm, referenced above.

In understanding and describing the Ranucci algorithm, certaindefinitions are useful.

HCT: hematocrit N.

Hb: hemoglobin (g/dL).

CPB: cardiopulmonary bypass.

T: temperature (° C.).

VO2=oxygen consumption (mL/min).

VO2i=oxygen consumption indexed (mL/min/m²).

DO2=oxygen delivery (mL/min).

DO2i=oxygen delivery indexed (mL/min/m²).

O2 ER=oxygen extraction rate N.

VCO2=carbon dioxide production (mL/min).

VCO2i=carbon dioxide production indexed (mL/min/m²).

Ve=ventilation (L/min).

eCO2=exhaled carbon dioxide (mmHg).

AT=anaerobic threshold.

LAC=lactates.

Qc=cardiac output (mL/min).

IC=cardiac index (Qc/m²), (mL/min/m²).

Qp=pump flow (mL/min).

IP=pump flow indexed (Qp/m²), (mL/min/m²).

CaO2=arterial oxygen content (mL/dL).

CvO2=venous oxygen content (mL/dL).

PaO2=arterial oxygen tension (mmHg).

PvO2=venous oxygen tension (mmHg).

a=arterial.

v=venous.

Sat=Hb saturation (%).

The following equations are useful in the Ranucci algorithm.

VO2=Qc×(CaO2−CvO2)in a normal circulation  (1)

VO2=Qp×(CaO2−CvO2)during CPB  (2)

DO2=Qc×CaO2 in a normal circulation  (3)

DO2=Qp×CaO2 during CPB  (4)

O2ER=VO2/DO2(%)  (5)

Hb=HCT/3  (6)

CaO2=Hb×1.36×Sat(a)+PaO2×0.003  (7)

CvO2=Hb×1.36×Sat(v)+PvO2×0.003  (8)

VCO2=Ve×eCO2×1.15  (9)

The oxygen consumption (VO2) is the sum of the metabolic needs of eachspecific organ and thus represents the metabolic needs of the wholeorganism. Under basal conditions (at rest), it is about 3-4 mL/min/kg,i.e. about 250 ml/min for a subject weighting 70 kgs. Applying equations(3) and (7), the oxygen delivery (DO2) may be calculated, and is about1000 mL/min. Therefore, a considerable functional reserve exists, sincethe DO2 is about 4 times greater than the VO2. The VO2 may increasedepending on the metabolic needs (basically under physical exercise, buteven in pathologic conditions like septic shock). A top level enduranceathlete may reach a maximal VO2 of about 5000 mL/min.

Of course, to meet these increasing oxygen demands, the DO2 mustincrease as well: it can reach, in an athlete during exercise, the valueof 6000 mL/min (Qc: 30 L/min with an unchanged arterial oxygen contentof 20 mL/dL). As a consequence, the O2 ER may increase up to 75%.

FIG. 14 is a diagram showing the relationship between DO2 and VO2 in anathlete during physical exercise. If the athlete (that, for example, isrunning a marathon) falls into the dark triangular zone (where the DO2is unable to support the VO2), the athlete is forced to use othermetabolic mechanisms in order to develop mechanical energy. Inparticular, the athlete will undergo anaerobic lactacid metabolism,which develops energy but at the expenses of lactic acid formation,local and systemic acidosis, and finally exercise stops usually within 2minutes. In other words, the VO2 is physiologically dependent on theDO2.

In the medical field, of course, the situation is different. The DO2 maypathologically decrease in case of: decreased arterial oxygen contentdue to anemia; decreased arterial oxygen content due to hypoxia; anddecreased cardiac output. However, due to the existence of theabove-mentioned physiological reserve, the VO2 may be maintained evenfor a DO2 decrease down to about 600 mL/min (DO2i 320 mL/min/m²), due tothe increased O2 ER.

FIG. 15 is a diagram showing the relationship between DO2 and VO2 in therange observed during medical conditions (i.e. cardiac operation). Belowa DO2 of 600 mL/min, VO2 starts decreasing. The patient meets, exactlyas the athlete, a lactic acidosis, with lactate (LAC) production. Inother words, the patient experiences a shock. The DO2 level below whichthe VO2 starts decreasing and becomes pathologically dependent on theDO2 is called the critical DO2 (DO2_(crit)). Maintaining the DO2 abovethis threshold is very important in many pathological conditions, toavoid an acidosis-shock status. The DO2_(crit) is higher during a septicshock.

Since 1994, in a paper published in Perfusion, Ranucci and coworkersdemonstrated that in a series of 300 consecutive patients that underwentmyocardial revascularization with CPB, the presence of a severehemodilution was an independent risk factor for a postoperative acuterenal failure (ARF). In particular, the cut-off value was identified atan HCT<25%.

Subsequently, other authors have demonstrated that the lowest HCT duringCPB was an independent risk factor for many “adverse outcomes” incardiac surgery. Stafford-Smith and coworkers, in 1998 (Anesth Analg),confirmed the relationship between hemodilution and ARF.

More recently, the lowest hematocrit on CPB has been recognized as anindependent risk factor for postoperative low cardiac output andhospital mortality by Fang and coworkers (Circulation, 1997), and for animpressive series of postoperative adverse events by Habib and coworkersin 2003 (J Thorac Cardiovasc Surg). The relationship betweenhemodilution and ARF has been subsequently confirmed by Swaminathan andcoworkers in 2003 (Ann Thorac Surg), Ranucci and coworkers 2004 and 2005(Ann Thorac Surg) and Karkouti and coworkers in 2005 (J ThoracCardiovasc Surg). The critical HCT value below which the ARF risksignificantly increases is located between 23% and 26%.

Almost all the authors ascribe this relationship to an insufficientoxygen supply (DO2) to the various organs. The kidney, in particular,due to its physiologic condition of hypoxic perfusion, seems to be athigh risk.

Surprisingly, all the studies demonstrating a relationship between HCTand ARF or other organ damages failed to consider that the HCT is onlyone of the two determinants of the DO2 during CPB: the other is the pumpflow (Qp). This would not influence the DO2 if the Qp was a constant,but this is not the case. In all the studies, the pump flow (Qp) variedfrom a Qpi of 2.0 L/min/m² to a Qpi of 3.0 L/min/m², and the variationwas dependent on the perfusion pressure. An HCT of 24% results in a DO2iof 230 ml/min/m² if the Qpi is 2.0 L/min/m², and of 344 ml/min/m² if theQpi is 3.0 L/min/m².

In a scientific paper in The Annals of Thoracic Surgery, Ranucci andcoworkers actually demonstrated that the DO2i, rather than the HCT, isthe best predictor of ARF. Moreover, in presence of perioperative bloodtransfusions, the DO2i remains the only determinant of ARF. TheDO2_(crit) identified in this paper is 272 ml/min/m², very close to theone previously defined as the DO2i below which the VO2 becomespathologically dependent on the DO2. In other words, maintaining theDO2i above this threshold allows a decrease in the hypoxic organdysfunction or the elimination of the hypoxic organ dysfunction; inpresence of a low HCT, an adequate increase of the Qp may minimize thedeleterious effects of hypoxemia. As a consequence, a continuousmonitoring of the DO2 is of paramount importance in order to limit thepostoperative complications, namely the renal ones.

Measuring a low HCT has poor clinical value, since the only possible(and arguable) countermeasure is a blood transfusion. On the other hand,the DO2 may be modulated by increasing the pump flow.

The level of DO2_(crit), below which the LAC production begins, isidentified by the concept of “anaerobic threshold” (AT). In athletes, itis the level of expressed mechanical power at which the LAC productionbegins; in a patient, it is the level of DO2_(crit), below which the LACproduction begins.

It has been demonstrated that the LAC value during CPB is predictive forpostoperative complications. The problem is that the LAC value is notavailable on-line, and only some devices (blood gas analyzers) provideit. It is however possible to make an “indirect” assessment of the AT.As a matter of fact, under steady conditions, the VO2/VCO2 ratio is aconstant, while during anaerobic lactacid metabolism the VCO2 increasesmore than the VO2. This happens because the lactic acid undergoes thefollowing transformation: H LAC+NaHCO₃=LAC Na+H₂CO₃ and the H₂CO₃ issplit into H₂O and CO₂, with a further CO₂ production.

FIG. 16 is a diagram showing the relationship between VO2 and VCO2. Therelationship between VCO2 and LAC production has been demonstrated in 15consecutive patients under CPB, in an experimental trial performed bythe inventor himself. In FIG. 17, the graphical relationship betweenVCO2 and LAC production is reported. From this relationship, it appearsthat a VCOi value of 60 ml/min/m² is a sensitive predictor of lacticacidosis.

Under normal resting conditions, oxygen delivery matches the overallmetabolic demands of the organs and the oxygen consumption (VO2) isabout 25% of the oxygen delivery (DO2), and energy is produced basicallythrough the aerobic mechanism (oxidative phosphorylation). When the DO2starts decreasing (due to a decreased cardiac output, extremehemodilution, or both), the VO2 is maintained until a “critical level”is reached. Below this critical point the oxygen consumption startsdecreasing, becoming dependent on the oxygen delivery, and the failingaerobic energy production is progressively replaced by anaerobicadenosine triphosphate production (pyruvate conversion to lactate).

As a result, blood lactate concentration starts rising, and numerousstudies have established the use of lactates as a marker of globaltissue hypoxia in circulatory shock. Under these circumstances, theanaerobic metabolism results in an excess of proton production andtissue acidosis; buffering of the protons by bicarbonate ions results,in turn, in an anaerobic carbon dioxide production (VCO2). Therefore,below the critical DO2, there is a linear decrease of both VO2 and VCO2,but due to the anaerobic CO2 production, the respiratory quotient(VCO2/VO2) RQ increases. When the critical DO2 is reached due to adecrease in cardiac output (cardiogenic shock), the above relationshipbecomes more complex.

Due to the reduced pulmonary flow and to ventilation-perfusion mismatch,the ability of the lung to eliminate carbon dioxide is impaired, andcarbon dioxide elimination and end-tidal carbon dioxide tension aredecreased. Consequently, carbon dioxide starts accumulating in thevenous compartment, and the venoarterial carbon dioxide gradient isincreased. In other terms, the VCO2 (intended as carbon dioxideproduction by the tissues) becomes progressively higher than carbondioxide elimination.

Under CPB conditions, the above pattern changes again. The artificiallung is much more efficient than the natural lung in terms of carbondioxide clearance, and is maintained even for a very low pump flow. Notby chance, under specific circumstances like deep hypothermia andaccording to the pH strategy, it is clinically needed to add carbondioxide to the gas flow in order to avoid dramatic and dangerouspatterns of hypocapnia. In this setting, the VCO2 is strictly correlatedto the carbon dioxide elimination.

Therefore, while in a normal setting the venous carbon dioxide tension(PvCO2) is inverse to the carbon dioxide elimination, during CPB the twoparameters are positively correlated. Subsequently, Ranucci andcoworkers found that the best predictor of hyperlactatemia during CPBwas the DO2/VCO2 ratio, with a cut off value around 5.0, and the VCO2,with a cut off value at 60 mL/min/m2.

In some embodiments, it is believed that low values of DO2 during CPBmay create an ischemic environment to the kidney. Extremely low valuesof DO2 may trigger anaerobic metabolism with lactate production. Thismay be detected using CO2-derived parameters

In some embodiments, therefore, the integrated perfusion system 14 mayinclude one or more of a pump flow reading device and a hematocrit valuereading device. The integrated perfusion 10 system includes an inputdevice 22 and a controller 20 that is programmed or otherwise configuredto compute the oxygen delivery (DO2i) value on the basis of the measuredpump flow (Qp), the measured hematocrit (HCT), the preset value ofarterial oxygen saturation (Sat(a)), and the preset value of arterialoxygen tension (PaO2) and a display.

In some embodiments, the perfusion system 14 also includes a CO2 readingdevice for continuously detecting exhaled CO2 (eCO2) at the oxygenatorgas escape of the HLM. The input device 22 allows the operator to inserta gas flow value (Ve) and the controller 20 computes the CO2 production(VCO2i) on the basis of the preset gas flow (Ve) value and the detectedexhaled CO2 (eCO2), and the output device 24 shows the calculated valueof CO2 production (VCO2i).

In some embodiments, the controller 20 is programmed or otherwiseconfigured to compare the above mentioned oxygen delivery (DO2i) valuewith a threshold value of oxygen delivery (DO2i_(crit)) and to triggeran alarm when the oxygen delivery (DO2i) value falls below the thresholdvalue of oxygen delivery (DO2i_(crit)). In one embodiment, the thresholdvalue of oxygen delivery (DO2i_(crit)) is preset by the operator at avalue of about 270 ml/min/m².

In some embodiments, the perfusion system 10 further includes atemperature detecting device configured to continuously measure a bodytemperature (T) of the patient and to send the temperature values to thecontroller 20, to be subsequently displayed by the output device 24. Thecontroller 20 may be programmed or otherwise configured to calculate,based on the temperature (T) of the patient, an oxygen deliverythreshold. In some embodiments, the controller 20 is programmed orotherwise configured to calculate the hemoglobin (Hb) value from thedetected hematocrit (HCT) value.

FIG. 18 shows a patient 101 laying on a surgical table 102. Anembodiment of a HLM 103, is connected to the patient 101. A HLM 103includes a venous extracorporeal circuit, collecting blood from thevenous system of the patient. A roller or centrifugal mechanical pump104 pumps the venous blood from a venous extracorporeal circuit towardsan oxygenator 105, whose role is removing CO2 from the venous blood andsupplying oxygen (O2). The blood oxygenated by the oxygenator 105, issent, again by the same roller or centrifugal pump 104, to an arterialextracorporeal circuit connected to the arterial system of the patient,therefore creating a total bypass of the heart and lungs of the patient.

The monitoring system 110, is operatively connected to the heart-lungmachine 103 and may include a processor that is able to performcalculations, as subsequently explained, and a monitor screen or display111 that provides an interface with the operator. Using a knob 50 (seenin FIGS. 20 and 21), an operator may manually input data.

Examples of data that may be manually inputted include, but are notlimited to, the height and weight of the patient and the arterial oxygensaturation (Sat(a)). While this value is usually 100 percent, in somesituations such as oxygenator malfunction, the value may decrease. Insome embodiments, the arterial oxygen saturation value may becontinuously or discretely (every twenty minutes or so) monitored by anexternal device that may be connected to the DMS 29. In someembodiments, if the Sat(a) value is not monitored, the DMS 29 may beprogrammed to assume that it is 100%.

The arterial oxygen tension value (PaO2) may also be manually entered.The PaO2 value is measured by the perfusionist on the arterial blood ofthe patient with blood gas analysis, using an adequate and specificdevice. In some embodiments, the arterial oxygen tension value may becontinuously or discretely (every twenty minutes or so) monitored by anexternal device connected to the DMS 29.

The gas flow value (Ve) may be manually entered. The Ve value isestablished by the perfusionist operating the heart-lung machine 103.Generally, the Ve is regulated with a flow-meter, according to thepatient's parameters. This Ve value rarely changes during a CPBprocedure, and therefore can be manually inserted by the operator.However, as an alternative, the monitoring system 110 may include anelectronic flow-meter connected to the heart-lung machine 103, tocontinuously detect the Ve value.

In some embodiments, the DMS 29 may be configured to calculate anddisplay the oxygen consumption rate (VO2) and/or the carbon dioxideproduction (VCO2). As noted above, the VO2 value may be calculated usingequation 2 and the VCO2 value may be calculated using equation 9:

VO2=Qp×(CaO2−CvO2)during CPB  (2)

VCO2=Ve×eCO2×1.15  (9).

In some embodiments, the Ve value (gas flow) may be automatically andcontinuously acquired from a gas blender that is connected to the HLM12. In some instances, the Ve value may be manually entered into the DMS29. In some embodiments, the expired CO2 value (eCO2) may becontinuously or discretely (about every twenty minutes or so) monitoredby an external device connected to the HLM 12. The eCO2 value may beseparately monitored and manually entered into the DMS 29.

In some embodiments, the monitoring device 110 is electrically connectedto the HLM 103, so as to continuously receive data collected by adequatesensors placed in specific positions of the heart-lung machine.Illustrative but non-limiting examples of continuously collected datainclude the patient's body temperature (T). The temperature T may becontinuously measured by a temperature probe 140 inserted inside theesophagus or the rectum or other organs of the patient. The temperatureprobe 140 sends an electronic signal of the temperature to a monitor ofthe HLM 103 visualizing, in real-time, the temperature value. In thiscase, it is sufficient to interface with an electrical connection themonitor of the HLM 103 with the monitoring device 110, for a continuousinput of the temperature value T.

Another monitored value includes the exhaled carbon dioxide (eCO2). TheeCO2 value is continuously measured through a CO2 detector 141 placed atthe gas escape of the oxygenator 105 to detect the sidestream CO2exhaled from the oxygenator 105. The CO2 detector 141 can be any kind ofCO2 detector among the various commercially available and re-usablecapnographs.

Another monitored value includes the hematocrit (HCT). The HCT value iscontinuously measured through a hematocrit reading cell 142 placedinside the arterial or venous circuit of the HLM 103. In someembodiments, the HCT value may be discretely measured, for example,about every twenty minutes or so by an external device that may beconnected to the DMS 29. In some embodiments, the HCT value may beindependently monitored and manually inputted into the controller 20and/or the DMS 29. For instance, in FIG. 18, the hematocrit reading cell142 is placed inside the arterial line between the pump 104 and theoxygenator 105. The hematocrit reading cell 142 is commerciallyavailable and disposable.

Another monitored value includes the pump flow rate (Qp). The Qp valueis continuously measured through the Doppler reading cell 143, placed onthe arterial line of the HLM 103. This kind of Doppler reading cell 143measures the blood flow on the basis of the Doppler principle (red cellsvelocity).

In some embodiments, if the pump 104 is a centrifugal pump, it isalready equipped with a Doppler reading cell 143. Conversely, if thepump 104 is a roller pump, the Doppler reading cell 143 may be added. Inthe alternative, the Doppler reading cell 143 may be omitted, since theroller pump head is provided with a flow measuring system. In this case,the data regarding the pump flow Qp is directly sent to the monitoringdevice 110.

With specific reference to FIG. 19, operation of the monitoring system110 is described below. The processor of the monitoring system 110includes a first computing program 112 that, based on the weight andheight of the patient as input by the operator calculates, according topre-defined tables, the body surface area (BSA) of the patient.

The BSA value is sent to a second computing program 113 that receivesthe input value of the pump flow Qp as detected by the pump 104 of theHLM 103. The second computing program 113 calculates the indexed pumpflow Qpi, according to the relationship QpI=Qp/BSA.

A third computing program 114 receives the input value HCT as detectedby the hematocrit reading cell 143 placed inside the venous or arterialline of the heart-lung machine. The third computing program 114, basedon the equation (6), calculates the hemoglobin value Hb. The Hb value issent to the display 111 and is displayed in a window 151 of the display111 (FIG. 20).

The pump flow indexed Qpi computed by the second computing program 113and the hemoglobin value Hb computed by the third computing program 114are sent to a fourth computing program 115 that receives as input valuesthe values of arterial oxygen saturation (Sat(a)) and arterial oxygentension (PaO2) manually entered by the operator. The fourth computingprogram 115, according to the equation (4), calculates the indexedoxygen delivery value (DO2i).

As shown in FIG. 20, the DO2i value is visualized in real time in awindow 153 of the display 111 and as a graphical pattern 152 (as afunction of time). The display 111 is provided with a chronometer window156 showing the time passed from the beginning of the CPB.

As shown in FIG. 19, the DO2i value is sent to a comparator 118 whichcompares it to a threshold value of DO2i_(crit) that is displayed in awindow 154 (FIG. 20) of the display 111. This threshold value may be setat 270 ml/min/m² at a temperature between 34° C. and 37° C., anddecreases as a function of temperature, in a linear fashion.

Therefore the threshold value of DO2i_(crit) be preset by the operatoror may be calculated by a computing program 117 depending on thetemperature value T determined by the temperature probe 140. Thetemperature T value determined by the probe 140 is sent to the display111 to be displayed in a window 155.

When the DO2i value falls below the DO2i_(crit), the comparing devicesends a control signal to an alarm 116 that is triggered, alerting theoperator of a potentially dangerous condition.

In some embodiments, the alarm 116 is not triggered by brief decreasesof the pump flow Qp (often needed during CPB). Therefore, the alarm 116could be set to be activated after 5 minutes of consecutive detection ofa DO2i below the DO2i. However, a recording of all the periods of lowflow can be made, to analyze and avoid the possibility that many shortperiods of low flow may create an additional effect. It is reasonable toconsider no more than 20 minutes (as a total) of DO2i below theDO2i_(crit) during a normal CPB lasting about 90 minutes. The monitoringdevice 110 is equipped with a computing program 119, which receives asinput values the exhaled carbon dioxide eCO2 as detected by the CO2sensor 141 and the gas flow Ve set by the operator. According to theseinput data, the computing program 119 calculates the indexed carbondioxide production VCO2i applying the equation (9).

The VCO2i value as calculated by the computing program 119 is sent tothe display 111 and displayed in real time in a window 157 (FIG. 20) inits graphical relationship 158 as a function of time.

The VCO2i value is sent to a second comparator 120 which compares itwith an anaerobic threshold value VCO2i_(crit) set by the operator; bydefault the VCO2i_(crit) is preset at 60 ml/min/m². As shown in FIG. 20,the display 111 is provided with a window 159 showing the value ofanaerobic threshold VCO2i_(crit) set by the operator.

Back to FIG. 19, when the VCO2i exceeds the VCO2i_(crit) an alarm signalis sent to a second alarm 121, which, when triggered, alerts theoperator of a warning condition. Moreover, as shown in FIG. 20, thedisplay 111 is provided with: a window 160 where the gas flow value Veset by the operator is displayed; a window 161 where the indexed pumpflow value Qpi arriving from the computing program 113 is displayed; anda window 162 where the body surface area of the patient is displayed ascalculated by the computing program 112.

In some embodiments, the monitoring system 110 may be equipped with adata recording system and a printer interface, and/or a digital datarecording system. The display 111 could include two configurations: acomplete configuration, as the one shown in FIG. 20, and a reducedconfiguration, only considering the DO2 parameter, as shown in FIG. 21.

In some embodiments, the DMS 29 may track and display a variety ofdifferent metabolic parameters. FIGS. 22 and 23 are screen capturesproviding illustrative but non-limiting examples of some of themetabolic parameters that can be displayed by the DMS 29. As discussedabove, some of these parameters are measured while other parameters maybe calculated by the DMS 29 using measured parameters. Examples ofparameters include index oxygen delivery (DO2i), indexed oxygenconsumption (VO2i), and indexed carbon dioxide production (VCO2i).Examples of ratios that may be displayed include DOi2/VCO2i, VCO2i/VO2iand VO2i/DO2i.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentinvention. For example, while the embodiments described above refer toparticular features, the scope of this invention also includesembodiments having different combinations of features and embodimentsthat do not include all of the above described features.

1. An integrated perfusion system comprising: a heart lung machineincluding a plurality of pump modules, each pump module having a controlunit; a controller in communication with each of the control units; aninput device in communication with the controller and configured toaccept operational settings information from a user; and an outputdevice in communication with the controller and configured to displayoperational parameters of the plurality of pump modules; a datamanagement system in communication with the controller, the datamanagement system including an RF sensor; and a processor incommunication with the RF sensor; and one or more disposable elementsconfigured to be used in conjunction with the heart lung machine andincluding an RFID tag programmed with identifying information that canbe read by the RF sensor and used by the processor to unlockfunctionality within the data management system.
 2. The integratedperfusion system of claim 1, wherein the data management system isconfigured to receive and record data from the heart lung machine andoptionally from external sources.
 3. The integrated perfusion system ofclaim 2, wherein the data management system is configured to displaydata received from the heart lung machine and optionally from externalsources.
 4. The integrated perfusion system of claim 1, wherein the oneor more disposable elements include one or more of a blood reservoir, anoxygenator, a heat exchanger, or an arterial filter.
 3. The integratedperfusion system of claim 4, wherein the blood reservoir comprises avenous blood reservoir, a suction blood reservoir, a vent bloodreservoir or a combination thereof.
 6. The integrated perfusion systemof claim 1, wherein the one or more disposable elements include apassive RFID tag.
 7. The integrated perfusion system of claim 1, whereinthe input device comprises a touch screen computer.
 8. The integratedperfusion system of claim 1, wherein the functionality comprises ametabolic algorithm.
 9. The integrated perfusion system of claim 1,wherein the RFID tag is further programmed with information identifyingperformance characteristics of the one or more disposable elements. 10.The integrated perfusion system of claim 9, wherein the data managementsystem is configured to display a priming volume simulator utilizing theidentified performance characteristics of the one or more disposableelements.
 11. A method of configuring an integrated perfusion systemincluding a heart lung machine and a data management system, the datamanagement system including an RF sensor, the method comprising stepsof: attaching a disposable component having an RFID tag to the heartlung machine; reading the RFID tag with the RF sensor; unlockingfunctionality within the data management system in accordance withinformation read from the RFID tag; and operating the unlockedfunctionality.
 12. The method of claim 11, wherein operating theunlocked functionality comprises displaying a metabolic algorithm. 13.The method of claim 11, wherein operating the unlocked functionalitycomprises displaying a priming volume simulator in accordance withinformation read from the RFID tag.
 14. The method of claim 11, furthercomprising displaying information provided from the RFID tag to the RFsensor.
 15. The method of claim 11, wherein attaching the disposablecomponent having an RFID tag to the heart lung machine precedes readingthe RFID tag with the RF sensor.